Marker Therapeutics, Inc. (MRKR) Q4 2016 Earnings Report, Transcript and Summary

Good afternoon and welcome to the TapImmune Year-end 2016 Business Update Conference Call. All participants will be listen-only-mode. [Operator Instructions]. After today's presentation, there will be an opportunity to ask questions. [Operator Instructions]. Please note this event is being recorded. I would now like to turn the conference over to Joshua Drumm. Please go ahead.

Thank you, Gary. Good afternoon and welcome to the TapImmune fourth quarter and year end 2016 investor conference call. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. During the call, we will make forward-looking statements within the meaning set forth in the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties, and include but are not limited to any of the following. Any statements other than the statements of historical fact regarding management's expectations, beliefs, goals and plans about the Company's prospects including its clinical studies for its cancer vaccine candidates' advancement of its PolyStart technology, future financial position, future revenues and projected costs and market acceptance of the Company's product candidates. More specifically forward-looking statements include any statements about our clinical development plans, and the timing cost and results thereof, projections as to the Company's future spending and cash position, expectations as to the timing and nature of anticipated regulatory action, possible product licensing or other business development transactions, any commercial plans and expectations, market projections for our product candidates and expectations as to manufacturing and product component cost. Our actual results may differ materially from these projections or estimates due to a variety of important factors including but not limited to uncertainties related to clinical development, regulatory approvals and commercialization. These risks are described in greater detail in TapImmune's filings with the Securities and Exchange Commission, which are available at tapimmune.com as well as the SEC's website. TapImmune may not actually achieve the goals or plans described in these forward-looking statements and investors should not place undue reliance on these statements. Please note that TapImmune does not intend to update forward-looking statements except as required by law. At this time, it is now my pleasure to turn the call over to Dr. Glynn Wilson, Chief Executive Officer of TapImmune. Glynn please go ahead.

Thanks Josh and good afternoon everyone and thank you for joining us on our first quarterly investor conference call. We plan to host similar corporate update calls to enhance transparency and highlight our progress, as we and our clinical partners advance our cancer vaccine candidates through multiple clinical trials. We'll also discuss our strategy for continuing to build shareholder value through successful clinical execution, as well as the upcoming milestone that we expect to achieve in the near and long-term. Joining me on the call today is Dr. John Bonfiglio, our President and Chief Operating Officer, who will provide further detail on our current and planned clinical programs. First, I'd like to provide a general overview of our Company for those who may be new to TapImmune and highlight some of our recent achievements. TapImmune is a clinical stage immune-oncology company that is distinguished by our focus on women's cancers. We are currently advancing two T-cell vaccine candidates in multiple phase 2 and phase 1/2a clinical trials. Our initial focus is on addressing the unmet need in women's cancers, specifically ovarian breast cancers, where reoccurrence rates are high following surgery and initial therapy. The time to reoccurrence is relatively short for these cancers, and survival prognosis is extremely poor once the cancer recurs. These cancers also tend to be resistant to most immunotherapies, which is why we believe we have a significant opportunity to improve the lives of these patients. Our novel immunotherapies are design to target both tumors and metastatic disease for intractable ovarian and breast cancer. Our T-cell cancer vaccine technology is engineered to overcome deficiencies of earlier approaches in this field. Our vaccines have the potential to be a powerful standalone therapy against a variety of cancers, as well as the central component of the leading combination immunotherapy, which is an exciting approach that many are undertaking in the clinic today. We are proud to be working in collaboration with industry and clinical leaders, including The Mayo Clinic, Memorial Sloan Kettering Cancer Center and AstraZeneca, all of which have thoroughly vetted our technology and recognized the value in advancing early candidates. This is based in large part on the data we've generated in Phase 1 clinical studies, which showed robust, sustained immune responses against our targets in over 90% of patients treated. We received orphan disease designation for the use of this vaccine in ovarian cancer and FDA fast track approval for one ovarian cancer indication. This further positions TapImmune to emerge as a leader in T-cell vaccine immunotherapy. I'd now like to tell you a little bit about our technology and how our vaccines are designed to elicit powerful and cancer immunity, as well as discuss what sets TapImmune apart from immunotherapy companies, based on our unique approach and market opportunity. Our technology is or has been derived from recent advances in cancer immunology and discovered, not in animals, but translational medicine, by observing what the immune system is responding to in cancer patients. As a result, our vaccines are comprised of a series of immunogenic peptides, derived from molecules that are over expressed on the surface of a majority of cancer cells we are targeting. Over expression of these molecules co-relates with disease reoccurrence and overall prognosis. We are looking to exploit the body's natural immunity to these relevant targets by identifying peptide and tissues that are being processed as part of a cancer patient's natural immune response. We then use those peptides as a basis for our vaccine. We use a carefully selected mix of both class1 and class 2 antigens, which is critical for stimulating both helper T-cells and tumor cells, to monitor robust T-cells response against the cancer sets. We expect this natural immune response to be effective against both the primary tumor as well as metastatic disease. We believe our vaccines will elicit a long-lasting memory, T-cell response against the cancer, and we are seeing some initial evidence of this in phase 1 studies. As I mentioned, we're focusing on treating women's cancers, because of a large and un-served patient population who are in great need of better treatment options. In the United States about 30,000 ovarian cancer patients, about 40,000 triple-negative breast cancer, and about -- and over 200,000 HER2/neu positive breast cancer patients are diagnosed each year. As the statistics are staggering about 1.6 million, there are about 1.6 million new cases worldwide of breast cancer and unfortunately about 500,000 women will die of this disease on an annual basis. Because our vaccines work differently, we feel we can provide benefit for women as a consolidation therapy to help prevent cancer recurrence, as well as second line therapy for women who are resistant to first line therapies. We're also doing some clinical work that combines our lead vaccine with an immune checkpoint inhibitor, to deliver the promise of immunotherapy to these patients who have few other treatment options. We are developing our vaccines as off-the-shelf products that are simple to manufacture and can be delivered by a simple injection. Selection of the molecular target and the antigens that make up the vaccine is key to ensuring that our vaccine will be effective for a majority of cancer patients in the disease we're targeting. The target for our lead vaccine candidate, TPIV 200 is Folate Receptor Alpha, which is over expressed in approximately 90% of ovarian cancer cells and more than 80% of triple-negative breast cancers. Folate Receptor overexpression is also correlated with the likelihood of cancerous recurrence. Yet importantly, some patients do develop spontaneous immunity against this natural molecule. That is the basis for our vaccine. TPIV 200 consists of five class II peptides, four within embedded class I T-cell epitope and one with an embedded antibody epitope. Importantly, humans vary genetically in their immune systems and TPIV 200 is expected to cover around 85% of human genotypes worldwide. This breadth of activity is supported by the results of our phase 1 studies. Our second lead vaccine is TPIV 110, which consists of five peptides targeting HER2/neu, which is overexpressed by approximately 30% of breast cancer patients. HER2/neu is also the target of a blockbuster monoclonal antibody therapy such as Herceptin or Parjeta, despite the fact that this approach is only effective for about 15% to 20% of HER2 positive patients, and can only be used for approximately a year. The unique mix of epitopes that combine TPIV 110 is expected to cover significant larger HER2/neu patient population than Herceptin, and remain effective for significantly longer. In addition, published data shows that the class I antigen in TPIV 110, that is one of the five antigens in the vaccine is the most effective class I antigen that we know in killing human breast cancer cells in culture. Based on these factors, we believe TPIV110 may be more efficacious for more women with this disease. Before I hand the call to John to go into further detail on our clinical programs, I'll quickly highlight some of our recent achievements. 2016 was an extraordinary year for our Company, setting us on a trajectory toward becoming a leading immune-oncology company and potential breakthrough for women with breast and ovarian cancer. As I mentioned, we successfully forged valuable relationships with important cancer centers and major pharmaceutical companies for collaboration in developing our vaccines. We also made important clinical progress with the initiation of multiple phase 2 clinical trials for TPIV200, including an immunotherapy combination with AstraZenica's checkpoint inhibitor, durvalumab in patients with platinum-resistant ovarian cancer, which is being conducted by Memorial Sloan Kettering Cancer Center. We also have Company-sponsored trials ongoing in Platinum sensitive ovarian cancer and triple negative breast cancer, as well as a planned Phase 2 study to be conducted by the Mayo Clinic and completely funded by a $13.3 million grant from the U.S. Department of Defense. In early 2016, the FDA granted us fast track designation for TPIV200 for treating platinum-sensitive ovarian cancer. As many of you may know, this important designation enables us to have frequent interaction with the FDA regarding the clinical development of TPIV200 for this indication and provides a pathway to accelerate the review of our new drug application once our clinical work is complete. We recently announced that we successfully completed a multi-ground production scale up as well as GMP manufacturing of the second clinical batch of TPIV200, which will be used to supply our ongoing Phase 2 study in Platinum-sensitive Ovarian cancer, as well as the upcoming Phase 2 study sponsored by Mayo Clinic for treating triple negative breast cancer. The successful release of our second lot of TPIV200s represented another important milestone for our lead vaccine candidate. As many of you may have seen, this morning we announced that our collaborators at Mayo Clinic received a second Department of Defense grant to fully fund a new Phase 2 study of our HER2/neu vaccine candidate in an early form of breast cancer. This then is the second clinical trial to be fully funded by a DoD grant, and we are excited for the study to begin later this year. We reached an important corporate milestone in early November last year when we successfully uplisted to the NASDAQ capital market. Listed on a national exchange expands our visibility and stock liquidity, and provides access to a broader investor base. When we were doing this, we also raised more than $9 million from the exercise of outstanding warrants and a small pipeline announcement [ph], and concurrently we removed, in excess of $26 million of derivative liability from our balance sheet. We are continuing to develop a stronger infrastructure and enhance capacity to [Indiscernible] institutional investors. It's all about clinical execution to drive greater shareholder value. I'll now hand the call over to John to provide greater detail on our clinical programs. John?

Thanks Glynn, and thank all of you for calling in today. Our lead vaccine candidate, TPIV 200 is currently being evaluated in three Phase 2 clinical studies, with the fourth study planned to initiate in 2017. The completed Phase 1 study of TPIV 200 that enrolled a Phase 2/3 ovarian parasenile [ph] and fallopian tube cancer patients show that 95% of the valuable patients generated robust immune responses of TPIV 200, and a 100% of those patients demonstrated T-cell responses lasting six months or longer. These positive results were published in the journal of clinical oncology, and has led to significant partnerships for the Phase 2 development. First study is being done in collaboration with AstraZeneca, sponsored by Memorial Sloan Kettering-Cancer Center. It's a single arm Phase 2 study that will enroll 40 women with Platinum-resistant ovarian cancer, who either progressed while receiving platinum based therapy such as carbo platinum or cyst [ph] platinum or have had disease progression within six months of completing platinum therapy. This study is evaluating TPIV 200 plus the adjuvant GMCSF in combination with AstraZeneca’s PD-L1 checkpoint inhibitor, durvalumab. TPIV 200 is administered as an intradermal injection once per monthly cycle, and durvalumab is given intravenously twice per cycle. The treatment period for the combination therapy is six weeks, six cycles and after which patients continue on durvalumab alone for another six cycles. Patients are then followed up until disease regression. Primary endpoint for this study's overall response rate is defined by the resist criteria, but certain predefined deviations from resist will be permitted if it's determined that patients are benefitting from the therapy. The enrollment began in May of 2016 and is more than 50% completed. We have anticipated the study report for an interim analysis and in second half of this year. We are also enrolling patients for the second ovarian cancer study sponsored by TapImmune. This one is a multicenter blinded randomized placebo controlled Phase 2 study, that will enroll 80 women with platinum sensitive ovarian cancer, which is defined it's have a tumor response or stable disease following platinum therapy. In this study, TPIV 200 is being evaluated as the consolidation therapy to reduce the rate of reoccurrence. The patients begin our study within eight weeks of completing their platinum therapy, with the primary endpoint of time to disease regression or recurrence. The two-arm study will randomize patients one-to-one to receive the active TPIV 200 plus GMCSF or placebo, just the GMCSF adjuvant alone. So 40 patients in each arm. Patients who will receive the vaccine intradermally every four weeks for six months, will be followed for 18 months after vaccination period. We will track the number of secondary endpoints including overall survival and response rate. This study opens for enrollment in several sites early this year, and is expected to complete enrollment in mid-2019. We have built in an interim analysis based on 50% enrollment, expect to have an interim result in the second half of 2018, depending upon enrollment. As a reminder, this program will benefit from FDA fast track designation, as well as orphan drug designation for ovarian cancer. TPIV 200 is also the subject of an 80-patient multicenter study currently enrolling women with stage IIb to stage III triple-negative breast cancer, who have completed surgery to remove the tumor as well as chemotherapy and radiation. Patients in this study will be randomized to one in four study arms, and will receive one of two doses of TPIV 200, either a high dose or a low dose. While TPIV 200 dose levels will enroll two study arms each, evaluating our vaccine plus GMCSF either with or without immune priming with cyclophosphamide prior to vaccination. Again, the vaccination period will be six months with TPIV 200 dosed every four weeks. Patients will be followed up until recurrence or receive a boost of vaccine every six months while their recurrence free. Primary endpoint in this study is immune response, meaning the emergence of T-cells and B-cells that are directed against Folate Receptor Alpha. In addition to safety and tolerability, key secondary endpoints include Folate Receptor Alpha expression on primary tumor cells and relapse free survival in relation to the anti-Folate Receptor immunity. In another words the duration of the immune response. We announced the dosing of the first patient in the study last year -- in June of last year and recently announced that we've surpassed the 25% enrollment benchmark, trading our first planned interim safety review. Based on a positive recommendation from an independent Data Safety Monitoring Board, we have continued to enroll patients. We expect to complete enrollment at the end of 2017 with top line data available in early 2018. Finally, TPIV will be evaluated in a second large Phase 2 study, also enrolling women with triple-negative breast cancer to be conducted by our collaborators at the Mayo Clinic. This two month 80 patient study is planned to commence sometime this year and is completely funded by a grant from the U.S. Department of Defense. We look forward to updating the market once the study begins to enroll patients. We also expect to initiate two studies this year for our second vaccine candidate, TPIV 110. In a completed Phase 1 study of TPIV 100, a predecessor to the current candidate, TPIV 110, which lacks the fifth peptide that was added to the current formulation, the vaccine was safe and well tolerated by HER2/neu positive breast cancer patients. In this study 95% of patients showing robust T-cell responses to two antigens and 75% of patients responded to all four antigens in TPIV 100. As I mentioned, an additional Class I antigen was added to create TPIV 110, which we expect to launch a Company sponsored Phase 1b/2a trial and HER2/neu positive breast cancer, following submission of updated IND. We've completed our pre-IND meeting with the FDA, and we expect to file the amended IND later this year. As we announced today, our collaborators at the Mayo Clinic recently announced a new Department of Defense grant that will be used to fund the second phase 1b/2a study of our HER2/neu vaccine, which will enroll women with ductal carcinoma in situ or DCIS breast cancer. This new study has the potential to validate our novel approach to establishing lasting immunity against both breast cancer and precancerous legions. If successful, our vaccine may one day replace standard surgery and chemotherapy, and potentially could become part of a routine immunization schedule for preventing breast cancer in healthy women. We look forward to initiating both of these studies in the coming months. Before I hand the call back to Glynn, I wanted to provide an existing preclinical technology developed by TapImmune called PolyStart. PolyStart is a protein expression technology that is designed to enhance the potency of DNA-based immunotherapies. By enhancing the expression of the antigens using proprietary vectors, we were able to potentially enhance the effectiveness of a given therapy, which gives TapImmune multiple opportunities to monetize this asset, both within oncology as well as in other areas where immunotherapies are used such as infectious disease. This technology is invented and owned by TapImmune and just recently last month we expanded the amount [ph] of property covering PolyStart through advancing preclinical studies and have created constructs for our breast and ovarian cancer targets which we may use for producing future vaccines. We're excited about this asset and we expect to see a sort of incremental value as we focus on advancing our vaccines through the clinic. With that, I'll turn the call to Glynn for financial update and closing remarks. Thank you.

Thanks John. For financial details, I'll direct the listeners to our Form 10-K filing which was actually filed today. There you can find our full financial results for the fourth quarter and for the full year 2016. On this call and on future quarterly update calls, I will just provide some of the key highlights, such as time of uplisting to the NASDAQ capital markets, we raised around $9 million to add to the cash we already have in hand, and that gives us sufficient cash to execute our programs this year. Before I open it up for Q&A, let me summarize on upcoming milestones. 2017 is shaping up to be another landmark year for TapImmune, driven by business and commercial execution. We expect solid clinical progress to be the primary value driver for the Company, and we are looking forward to several upcoming catalysts as we focus on advancing our clinical pipeline as efficiently as possible. Our goal is to complete Phase 2 proof-of-concept studies for TPIV200, three of which are currently enrolling patients. As we've mentioned, we have surpassed 50% enrollment in our Memorial Sloan Kettering sponsored Phase 2 combination study with AstraZenica's checkpoint inhibitor and we expect to report results of an interim analysis in the second half of this year. For TapImmune's sponsored study TPIV200 for treating triple negative breast cancer, we anticipate completing enrollment by the year end with top-line results expected sometime in 2018. Furthermore, Mayo clinic has announced plans to commence two Department of Defense funded studies of our two vaccine candidates, one in triple negative breast cancer and the other in ductal carcinoma in situ later this year. We will also move TPIV110 into our HER2/neu positive breast cancer study as soon as possible once our amended IND is accepted. In addition, we will accelerate development of our exciting new technology, PolyStart as a clinical candidate. Having being involved since the start of the research on PolyStart, I think it's a next generation vaccine technology that has enormous potential and widespread use. Another goal we have to continue formalizing industry relationships, potentially giving us more commercial reach. We continue to have discussions with a number of high-quality companies and will continue these conversations as we get close to the Phase 2 data for our programs. In addition to finding commercial partners, we would like to continue exploring combination therapies, such as our collaboration with AstraZeneca. We believe combination immunotherapy will have tremendous impact on how patients are treated for their disease, and we believe our T-cell vaccines are well suited for such combination arrangements. We are always opportunistically evaluating potential synergies in terms of other technologies for licensing, acquisition or co-development. We would likely remain focused on cancer immunity and women's cancers. Finally, we are working to establish our collaborations in both oncology and viral disease for our PolyStart technology, which we feel will be attractive to a number of key players in these fields, some of whom have already expressed interest. So as you can see, there is a lot to look forward to as a TapImmune shareholder. The key aim is clearly to build long-term value with your continued support. We also look forward to hosting additional quarterly update calls, so you can continue to track our strong focus in the clinic and movement towards achieving our strategic goals. Finally, I think it's very important to say that all of us at TapImmune share common goals of greatly improving and potentially saving the lives of patients who can be treated with our products. And with that, I'd like to thank all of you for joining us, and operator, you may open the lines for questions.

[Operator Instructions] The first question comes from Gary Anderson with Micro Cap Research. Please go ahead.

Hello, Glynn and John. Thanks for the update and congratulations on having four different Phase 2 studies in progress with world class partners. I don’t know if I've ever seen a company with a market cap under $40 million that have that. There might be one out there. If there is I haven’t seen it yet. So congratulations on that. I was wondering if you could talk a little bit more about PolyStart, because I think that's very exciting technology, and I think I read somewhere, where you had already done a preclinical study or some trail at Mayo Clinic towards the development of an improved small pox vaccine. Can you talk about that earlier study on PolyStart and what it revealed?

Sure. Gary, it's Gylnn Wilson here. And thanks for the question. We get the comments about our market cap at lot of the time, and you are absolutely right. For a company that has four Phase 2 clinicals, our market cap is extremely low. But we see that as a great opportunity for new investors and the existing shareholders to join us and buy stock. With respect to PolyStart; PolyStart is an exciting technology and its received two patents or patent allowances, one in July last year and one last month, and it covers the -- the PolyStart portion is -- you know in high school biology one DNA makes one RNA makes one protein? Well in PolyStart, it's one DNA makes one RNA, makes at least four proteins. So you're getting multiple initiation sites for the translation into peptides or proteins. So it gives a bigger signal for a DNA vector that can be used as a vaccine technology. PolyStart is one component and it's collaboratively [ph] used as an alternative code on for the initiation, than is conventional. The second part of the structure is the way you encode for you antigens and you can mix and match antigens. You can use the same antigens that you're using as peptides and use this as a booster strategy. And so we think it's got enormous potential involved, oncology NFX disease. We have very strong patent position, which will go out to 2034. The proof-of-concept to PolyStart was done in collaboration with Mayo Clinic, using vaccines RS peptides that if you like is just a smallpox vaccine. We know that those peptides on their own could protect mice against a lethal dose of smallpox. So it's a potential vaccine. But we know that by putting and coding the DNA for those peptides in PolyStart, and then transfecting cells and then exposing those cells to a vaccine, those cells could be killed. So in other words the signal from PolyStart was coming out to the surface of those cells. We decided for commercial reasons that we were not going to pursue a smallpox vaccine commercially, but if there's a spree of the intro into a whole area of viral disease and potential for other viral indications.

[Operator Instructions] Showing no further questions. This concludes our question-and-answer session. I would like to turn the conference back over to Glynn Wilson for any closing remarks.

Yes, I'd just like to thank everybody for joining us today. We look forward to speaking with you again soon. Please visit our website at www.tapimmune.com where we try to keep that as up to date as possible on our progress and we welcome your input in the future. Thank you.

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.